ADC Candidate Utilizing Rigachem Bio Technology Receives FDA Orphan Drug Designation

Securing FDA Support for Osteosarcoma Treatment Development
First-in-Human Phase 1 Trial Scheduled for Second Half of the Year

Rigachem Bio announced on June 4 that its partner, SOTIO Biotech, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the antibody-drug conjugate (ADC) candidate 'SOT106' for the treatment of osteosarcoma.

Logo image of Ligachem Bio company. Ligachem Bio

SOT106 is a candidate in which SOTIO's LRRC15-targeted antibody is combined with Rigachem Bio's ADC platform technology, 'Conjuall.'

LRRC15 is a protein known to be expressed at low levels in normal tissue but highly expressed in various sarcoma cancer cells and the tumor microenvironment. According to the companies, preclinical studies have confirmed the anti-cancer efficacy and tolerability of SOT106 in models of soft tissue sarcoma and osteosarcoma. SOTIO plans to begin the first-in-human clinical trial for SOT106 in the second half of this year.

Osteosarcoma is the most common primary bone cancer in children and adolescents, with poor prognosis for patients with recurrence or metastasis and limited treatment options. Receiving FDA Orphan Drug Designation provides benefits such as up to seven years of market exclusivity after approval, reduced regulatory fees, and regulatory support during the development process.

Radek Spisek, CEO of SOTIO, stated, "Osteosarcoma is an area where there has been little therapeutic innovation for decades. With this designation, we plan to accelerate the clinical development of SOT106."

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